You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Metformin hydrochloride; rosiglitazone maleate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for metformin hydrochloride; rosiglitazone maleate and what is the scope of freedom to operate?

Metformin hydrochloride; rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Sb Pharmco and Teva, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Recent Clinical Trials for metformin hydrochloride; rosiglitazone maleate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
GlaxoSmithKlinePhase 1
Daiichi Sankyo Inc.Phase 3
Daiichi Sankyo, Inc.Phase 3

See all metformin hydrochloride; rosiglitazone maleate clinical trials

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AVANDAMET Tablets metformin hydrochloride; rosiglitazone maleate 1 mg/ 500 mg, 2 mg/ 500mg 4 mg/ 500 mg 2 mg/ 1000 mg 4 mg/ 1000 mg 021410 1 2004-10-22

US Patents and Regulatory Information for metformin hydrochloride; rosiglitazone maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-003 Oct 10, 2002 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-004 Aug 25, 2003 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for metformin hydrochloride; rosiglitazone maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-003 Oct 10, 2002 ⤷  Subscribe ⤷  Subscribe
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-001 Oct 10, 2002 ⤷  Subscribe ⤷  Subscribe
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Metformin hydrochloride; rosiglitazone maleate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metformin Hydrochloride and Rosiglitazone Maleate

Introduction

The pharmaceutical market for antidiabetic drugs, particularly metformin hydrochloride and rosiglitazone maleate, is driven by several key factors including the growing prevalence of type 2 diabetes, advancements in medical technology, and increasing investments in research and development.

Growing Prevalence of Type 2 Diabetes

The global prevalence of type 2 diabetes is on the rise, driven by factors such as obesity, sedentary lifestyles, and an aging population. This increasing demand for effective antidiabetic medications has significantly impacted the market dynamics for drugs like metformin hydrochloride and rosiglitazone maleate[3].

Mechanism of Action and Clinical Efficacy

Metformin Hydrochloride

Metformin hydrochloride is a biguanide that enhances glucose uptake in peripheral tissues and reduces hepatic gluconeogenesis. It is a first-line treatment for type 2 diabetes due to its efficacy in lowering blood glucose levels and its favorable safety profile[1][2].

Rosiglitazone Maleate

Rosiglitazone maleate, a thiazolidinedione, improves glycemic control by increasing insulin sensitivity in muscle and adipose tissue and inhibiting hepatic gluconeogenesis. When combined with metformin, it offers a synergistic effect, significantly improving glycemic control, insulin sensitivity, and beta-cell function compared to either drug alone[1][2].

Market Segmentation

By Type

The metformin hydrochloride market is segmented into different types, including metformin HCL and metformin DC (delayed-release). These variations cater to different patient needs and preferences, contributing to the market's growth[3].

By Application

The market is also segmented by application, with metformin hydrochloride tablets and extended-release tablets being the primary forms. The availability of these different formulations helps in managing the condition more effectively and increases market demand[3].

Combination Therapy: AVANDAMET

The combination of rosiglitazone maleate and metformin hydrochloride, known as AVANDAMET, has been shown to be highly effective in clinical trials. This combination therapy has demonstrated significant improvements in fasting plasma glucose (FPG) and HbA1c levels compared to monotherapy with either drug. This synergistic effect has made AVANDAMET a preferred choice for many patients with type 2 diabetes[1][2].

Financial Trajectory

Market Size and Growth

The global metformin hydrochloride market is expected to grow significantly over the forecast period, driven by increasing investments in the pharmaceutical sector, advancements in medical technology, and the growing prevalence of type 2 diabetes. The market size is projected to increase due to the constant demand for antidiabetic medications and the expanding healthcare infrastructure in both developed and developing countries[3].

Revenue Growth Rate

The revenue growth rate of the global metformin hydrochloride market is anticipated to be robust, fueled by factors such as the increasing adoption of precision medicine, the need for early diagnosis, and the growing demand for home care settings. The market is expected to benefit from these trends, especially during the ongoing pandemic[3].

Key Drivers and Challenges

Drivers

  • Growing Prevalence of Type 2 Diabetes: The increasing number of patients with type 2 diabetes globally is a major driver for the market.
  • Technological Advancements: Improvements in healthcare infrastructure and the adoption of rapid testing and point-of-care diagnosis are driving market growth.
  • Investments in R&D: Increased funding by public and private sectors in pharmaceutical research and development is boosting market revenue[3].

Challenges

  • Side Effects and Safety Concerns: While the combination of rosiglitazone and metformin is generally well-tolerated, there are potential side effects and safety concerns, such as cardiovascular risks associated with rosiglitazone, which can impact market growth.
  • Regulatory Hurdles: Strict regulatory requirements and the need for continuous clinical trials to ensure safety and efficacy can pose challenges to market expansion[2].

Regional Outlook

The global metformin hydrochloride market is segmented into several major regions, each with its own growth dynamics. Developed countries with advanced healthcare systems and increasing awareness about diabetes management are significant contributors to the market. However, developing countries are also showing promising growth due to improvements in healthcare infrastructure and increasing access to antidiabetic medications[3].

Industry Insights and Expert Opinions

"The combination of metformin and rosiglitazone offers a rational therapeutic approach to the treatment of type 2 diabetes, especially in patients who are inadequately controlled with metformin monotherapy." - [Clinical Efficacy Review][1]

Statistical Highlights

  • Clinical Trials: In a 26-week study, patients treated with the combination of metformin and rosiglitazone showed a statistically significant improvement in FPG and HbA1c levels, with a mean treatment effect for FPG of –56 mg/dL and a mean treatment effect for HbA1c of –0.8% over metformin alone[2].
  • Market Size: The global metformin hydrochloride market is expected to grow significantly, driven by the increasing prevalence of type 2 diabetes and advancements in medical technology[3].

Conclusion

The market for metformin hydrochloride and rosiglitazone maleate is poised for significant growth, driven by the increasing demand for effective antidiabetic medications, technological advancements, and investments in R&D. While there are challenges related to side effects and regulatory hurdles, the synergistic benefits of combination therapy and the expanding healthcare infrastructure globally are key factors driving this market forward.

Key Takeaways

  • The combination of metformin hydrochloride and rosiglitazone maleate offers a highly effective treatment option for type 2 diabetes.
  • The global metformin hydrochloride market is expected to grow significantly due to the increasing prevalence of type 2 diabetes and advancements in medical technology.
  • Technological advancements and investments in R&D are major drivers of market growth.
  • Regulatory hurdles and side effects are challenges that need to be addressed.

FAQs

Q: What is the primary mechanism of action of metformin hydrochloride? A: Metformin hydrochloride enhances glucose uptake in peripheral tissues and reduces hepatic gluconeogenesis[1][2].

Q: How does rosiglitazone maleate improve glycemic control? A: Rosiglitazone maleate improves glycemic control by increasing insulin sensitivity in muscle and adipose tissue and inhibiting hepatic gluconeogenesis[1][2].

Q: What are the benefits of combining metformin hydrochloride and rosiglitazone maleate? A: The combination therapy significantly improves glycemic control, insulin sensitivity, and beta-cell function compared to either drug alone[1][2].

Q: What are the major drivers of the global metformin hydrochloride market? A: The major drivers include the growing prevalence of type 2 diabetes, technological advancements, and increasing investments in R&D[3].

Q: What are some of the challenges facing the market for metformin hydrochloride and rosiglitazone maleate? A: Challenges include potential side effects and safety concerns, particularly cardiovascular risks associated with rosiglitazone, and regulatory hurdles[2].

Sources

  1. Rosiglitazone maleate/metformin hydrochloride: a new formulation ... - PubMed
  2. AVANDAMET - accessdata.fda.gov - FDA
  3. Metformin Hydrochloride Market Analysis, Industry Size, Share ... - Biospace
  4. A Meta-analysis Comparing the Effect of Thiazolidinediones on ... - JAMA Internal Medicine
  5. Simultaneous estimation of metformin and rosiglitazone in ... - AWS

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.